Fatima Dumicz-Clinical Data Manager
Check rate
Experience
Clinical Data Manager
Consultant – Clinical Data Management & Clinical Operations
- Served as a DM contractor for Mirum Pharmaceuticals between 2025-02-01 and 2026-05-31, leading end-to-end clinical data management activities
- Coordinated a significant networking event for HEMEX (Swiss CRO), fostering connections within the Swiss biotech ecosystem
- Engaged with stakeholders to explore innovative models that simplify execution and reduce operational burdens for clinical trials
Project Oversight Lead / Senior Clinical Data Manager
Aixial
- Led end-to-end Data Management activities for global Phase I–III clinical trials across multiple therapeutic areas
- Provided Data Management input into protocol development, protocol deviations and data quality oversight
- Coordinated eCRF development, UAT testing, and data review tools supporting in depth Central Data Review activities
- Managed Central Data Review, query management, data cleaning, and database lock activities
- Oversaw CRO/vendor performance, ensuring quality, compliance, and timely study delivery
- Collaborated with cross-functional stakeholders to support data review, issue resolution, and study oversight
- Contributed to SOP development, process improvements, QC activities, and regulatory compliance
Study Data Manager / Project Manager Data Management
ICON
- Managed full Data Management lifecycle across multiple trials
- Coordinated CRF build, data validation, and query workflows
- Worked closely with clinical development stakeholders and biostatistics teams
- Ensured timely delivery of DB lock and clean datasets
Data Team Lead
IQVIA
- Led Data Management team activities and acted as primary sponsor interface
- Planned and tracked trial deliverables and ensured alignment with timelines
- Managed CRO/vendor performance and cross-functional coordination
- Reported trial metrics and supported operational decision-making
Data Coordinator II
Premier Research
- Supported CRF design, data cleaning, and regulatory compliance activities
Clinical Data Manager
MSD
- Supported EDC setup and testing, database lock, query management
Industry Experience
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Experienced in Pharmaceutical, Biotechnology, and Healthcare.
Business Area Experience
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Experienced in Research and Development, Project Management, Quality Assurance, Business Intelligence, and Operations.
Summary
With a strong foundation in clinical data, the core of evidence in every clinical trial, I understand how to align stakeholders, manage complexity, and ensure reliable outcomes. I’m a good listener and proactive collaborator who leads with clarity and focus to keep studies on track
Skills
Edc Systems: Medidata Rave, Oracle Inform, Redcap, Veeva Vault, Datalabs
Ctms: Veeva Systems
Data & Analytics: Sql, Advanced Excel
Project Tools: Microsoft Project, Trello
Standards: Cdisc (Cdash, Sdtm), Ich-Gcp, Fda, Gdpr
Clinical Processes: Ecrf Design, Uat, Edit Checks, Query Workflows, Ae/Sae Reconciliation, Db Lock, Data Transfers
Clinical Data Management
Clinical Project Management
Clinical Operations Project Management
Clinical Trial Management
Medidata Rave
Veeva Vault
Inform
Redcap
Sql
Data Management Plan (Dmp)
Annotated Crf (Acrf)
Data Validation Specifications (Dvs)
Statistical Analysis Plan (Sap)
Query Management
Data Cleaning
Ae/Sae Reconciliation
Epro Integration
User Acceptance Testing (Uat)
Edit Checks
Database Lock
Protocol Review
Clinical Systems Implementation
Regulatory Compliance
Ich-Gcp
Fda
Mdr
Iso14155
Vendor Oversight
Cro Management
Risk Mitigation
Trial Documentation
Sop Development
Study Start-Up
Trial Execution
Project Planning
Clinical Study Close-Out
Timeline Management
Stakeholder Communication
Site Activation
Monitoring Oversight
Cra Liaison
Enrollment Tracking
Etmf Oversight
Issue Resolution
Cross-Functional Leadership
Trial Milestones
Clinical Trial Governance
Audit And Inspection Readiness
Patient Recruitment
Safety Data Coordination
Biostatistics Collaboration
Clinical Trial Budget Tracking
Global Clinical Trials
Vendor Management
Site Management
Investigator And Site Relationship Management
Quality Control Of Clinical Data
Cdisc
Cdash
Sdtm Standards
Gdpr
Hipaa
Phase 1
Phase 2
Phase 3
Phase 4
Phase I
Phase Ii
Phase Iii
Phase Iv
Ivrs
Languages
Education
HAW Hamburg
Health Sciences · Hamburg, Germany
Kozminski University
Postgraduate Studies, Clinical Trials · Clinical Trials · Warsaw, Poland
University of Southern Denmark (SDU)
MSc Public Health · Public Health · Denmark
Statistics
Experience
Global Experience
Expertise
Qualifications
Profile
Frequently asked questions
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